Gastric Ultrasound Feeding Tube Placement Confirmation Study

NCT06595537 | Recruiting DMC

• 1 other identifier: NL77930.058.21
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Objective This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients. Study Design A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who require GFT placement. Patients will undergo ultrasound by an ultrasonographer (USG) after receiving a new or replaced GFT. The USG will assess the presence or absence of a "mosaic sign" after insufflation of 20 mL of air through the GFT. The mosaic sign indicates proper GFT placement in the stomach. Methods All ultrasonographic measurements will be recorded and saved in a central picture archiving and communication system (PACS). The images will be labeled with the deepness of the GFT (20 cm, 50 cm, or tracheobronchial) and anonymized before being presented to an intensivist expert in USG for interpretation. Hypothesis A 20 mL air insufflation via a GFT at the esophageal level or via a suction catheter in the tracheobronchial system will not produce a "mosaic sign" on ultrasound. This sign will only be present if the GFT is properly positioned in the stomach.

Conditions

Gastric Feeding Tubes; Ultrasound

Keywords

gastric ultrasound; Gastric feeding tube; Point of care ultrasound

Outcome Measures

Primary Outcomes (1)

• Test effectiveness of ultrasound in determining gastric feeding tube position in stomach.

  To assess the effectiveness of the test we will calculate its sensitivity and specificity. Sensitivity in this case being the proportion of images categorized as having a "mosaic sign present" by the blinded intensivist and indeed representing a gastric GFT localisation (objectivized by CXR). Specificty being the proportion of images categorized as "mosaic sign absent" and representing a non-gastric GFT localisation ( Air insuflation at 20cm GFT insertion and in tracheal canula (TB)). Sensitvity and Specificity will be expressed as a percentage as well as false positive and false negative rates. With this information we will be able to calculate the Likelihood Ratio (LR) for a positive result and for a negative result. The analysis will be done using the statistical program SPSS.

  ultrasound control of gastric feeding tube, confirming with X-ray

Secondary Outcomes (1)

• Correlating results with basline patient demographic, ventilator settings and post procedure chest x-ray findings.

  baseline and post procedure ( gastric feeding tube) chest x-ray

Study Arms (1)

Ultrasound control of air insufflation in tracheobronchial suction catheter, oesofagus and stomach

Patients will receive a gastric feeding tube. At mid-esophagus level and at gastric level, placement of the gastric feeding tube will be controlled through doppler-ultrasound after air-insufflation. Ultrasound control after air insufflation will also take place after placing a suction catheter through the endotracheal tube in the trachea. Finally the gastric feeding tube placement will be confirmed with chest X-ray.

Device: Hand held ultrasound

Interventions

Hand held ultrasound DEVICE

Determination of gastric feeding tube position with the use of Lumify handheld ultrasound

Also known as: Lumify handheld ultrasound

Ultrasound control of air insufflation in tracheobronchial suction catheter, oesofagus and stomach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of tracheally intubated ICU patients in need of GFT placement or replacement, who are willing to participate in the study and provide informed consent.

You may qualify if:

• Being tracheally intubated

You may not qualify if:

• Need a gastric feeding tube
• Given informed consent directly
• Does not need a gastric feeding tube and doesn't have one.
• Laparotomy wound interfering with abdominal ultrasound.
• Patient in prone position
• No informed consent

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Ledien University Medical Center

Leiden, South Holland, 2315VA, Netherlands

RECRUITING

Related Publications (7)

• Gomes GF, Pisani JC, Macedo ED, Campos AC. The nasogastric feeding tube as a risk factor for aspiration and aspiration pneumonia. Curr Opin Clin Nutr Metab Care. 2003 May;6(3):327-33. doi: 10.1097/01.mco.0000068970.34812.8b.

  PMID: 12690267 BACKGROUND

• Lo JO, Wu V, Reh D, Nadig S, Wax MK. Diagnosis and management of a misplaced nasogastric tube into the pulmonary pleura. Arch Otolaryngol Head Neck Surg. 2008 May;134(5):547-50. doi: 10.1001/archotol.134.5.547. No abstract available.

  PMID: 18490579 BACKGROUND

• Wendell GD, Lenchner GS, Promisloff RA. Pneumothorax complicating small-bore feeding tube placement. Arch Intern Med. 1991 Mar;151(3):599-602.

  PMID: 1848058 BACKGROUND

• Wong KW, Chan HH, Wong CP, Chan MY, Chau JCW, Wong TW. Using color flow detection of air insufflation to improve accuracy in verifying nasogastric tube position. Am J Emerg Med. 2017 Feb;35(2):333-336. doi: 10.1016/j.ajem.2016.12.046. Epub 2016 Dec 21.

  PMID: 28038826 BACKGROUND

• Vigneau C, Baudel JL, Guidet B, Offenstadt G, Maury E. Sonography as an alternative to radiography for nasogastric feeding tube location. Intensive Care Med. 2005 Nov;31(11):1570-2. doi: 10.1007/s00134-005-2791-1. Epub 2005 Sep 20.

  PMID: 16172849 BACKGROUND

• Chenaitia H, Brun PM, Querellou E, Leyral J, Bessereau J, Aime C, Bouaziz R, Georges A, Louis F; WINFOCUS (World Interactive Network Focused On Critical Ultrasound) Group France. Ultrasound to confirm gastric tube placement in prehospital management. Resuscitation. 2012 Apr;83(4):447-51. doi: 10.1016/j.resuscitation.2011.11.035. Epub 2011 Dec 29.

  PMID: 22209831 BACKGROUND

• Kim HM, So BH, Jeong WJ, Choi SM, Park KN. The effectiveness of ultrasonography in verifying the placement of a nasogastric tube in patients with low consciousness at an emergency center. Scand J Trauma Resusc Emerg Med. 2012 Jun 12;20:38. doi: 10.1186/1757-7241-20-38.

  PMID: 22691418 BACKGROUND

Study Officials

• Jorge E Lopez Matta, M.D.

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge E. Lopez Matta, M.D.

CONTACT

+316715269111; J.E.Lopez_Matta@lumc.nl

David J. Van Westerloo, M.D., pHD

CONTACT

+316715269111; D.J.van_Westerloo@lumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: September 19, 2024
• Study Start: December 18, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available 6 months after publication
• Access Criteria: IPD Sharing Access Criteria: The anonymized IPD will be shared with qualified researchers affiliated with academic, healthcare institutions, or regulatory authorities, with a focus on diagnostic ultrasound or gastric feeding tube placement. Data will be shared for secondary analyses related to diagnostic methods, ultrasound efficacy, and critical care. Commercial use will require special approval. Requests must include a research proposal, objectives, and ethical approval. Data will be accessed via secure repositories after approval. A committee, including the principal investigator and an independent ethics reviewer, will assess requests based on scientific merit, relevance, and ethical standards. Approved researchers must sign a data-use agreement.

Locations

NL (1)